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Automated Daytime Adaptive Deep Brain Stimulation Parameter Optimization in Patients Implanted With Percept Neurostimulator

RecruitingNAAges 25 Years - 75 YearsAllUniversity of California, San Francisco
NCT07682311 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Parkinson's disease (PD) affects \~1% of people over 60 years old, is highly disabling and represents a large economic burden. While dopaminergic medications effectively treat motor symptoms early in the disease, most patients develop complications, including motor fluctuations and dyskinesias, which can be partially managed by deep brain stimulation (DBS). This surgical therapy consists of delivering continuous electrical stimulation through electrodes permanently implanted in basal ganglia nuclei, with a pulse generator and battery unit implanted in the chest. However, conventional DBS therapy is delivered with constant stimulation parameters, referred to as constant deep brain stimulation (cDBS), that are unresponsive to patient activities or to variations in the severity of symptoms during daily life. This leaves many patients under- or over-stimulated during parts of the day. To ad

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 25-75. 2. Diagnosis of idiopathic PD. 3. Patient has undergone surgical intervention with deep brain stimulation (Percept device) for their disorder at least 2 months prior to recruitment. 4. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA)). 5. Signed informed consent. 6. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment. 7. Patient has been on cDBS for at least two months and still experiences significant residual motor fluctuation while on cDBS. Consequently, patient is undergoing aDBS treatment currently or was recommended aDBS as part of clinical care to manage their residual motor fluctuation. 8. Has available cDBS Timeline LFP and stimulation data lasting at least 1 day. 9. To be enrolled in the clinical trial phase of the study, patient will need to consent to reverting back to their baseline cDBS settings for all required cDBS testings. Exclusion Criteria: 1. Patient meets criteria for a psychogenic movement disorder. 2. Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS). 3. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
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What it tests

  • Medtronic Percept Deep Brain Stimulation (adaptive DBS)
  • Medtronic Percept Deep Brain Stimulation (cDBS)
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Where

1 site
University of California San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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